45 Participants Needed

Robotic Balance Training + Brain Stimulation for Stroke

(NEUROBALANCE Trial)

VS
KG
Overseen ByKathleen Goworek, B.S.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a combination of robotic balance training and gentle brain stimulation (high-definition transcranial direct current stimulation) can improve balance and posture in stroke survivors. It includes three groups: one receives both robotic training and real brain stimulation, another receives training with sham stimulation, and the last group receives regular therapy. The trial targets individuals who had a stroke over six months ago and continue to experience balance and walking difficulties. Participants will undergo 15 sessions over five weeks, and researchers will assess balance improvements. Feedback on the treatments will inform future therapy plans. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future stroke recovery therapies.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it mentions that participants should not plan to change their medication in the next four months. It's best to discuss your specific medications with the trial team.

What prior data suggests that this combined intervention is safe for stroke patients?

Research has shown that high-definition transcranial direct current stimulation (HD-tDCS) combined with robotic walking exercises can improve balance and movement. One study found that participants experienced better walking and balance after receiving real HD-tDCS with robotic training, suggesting the treatment is generally safe and effective for enhancing movement.

However, other studies have reported mixed results. In some instances, transcranial direct current stimulation (tDCS) with robotic training did not significantly enhance arm strength or movement speed. These mixed outcomes indicate that while benefits exist, effectiveness can vary among individuals.

Overall, HD-tDCS with robotic training appears safe, with some studies noting significant improvements. As with any treatment, individual responses may differ. Those considering this trial should discuss potential risks and benefits with their healthcare providers.12345

Why are researchers excited about this trial?

Researchers are excited about the combined approach of robotic balance training with brain stimulation for stroke recovery because it introduces a novel way to enhance rehabilitation. Unlike standard physical therapy, this method uses a robotic balance platform, Hunova, to precisely target and improve balance and postural control. Furthermore, it incorporates high-definition transcranial direct current stimulation (HD-tDCS) to specifically stimulate the leg motor area, potentially accelerating neural recovery. This innovative combination aims to offer more targeted and effective rehabilitation, which could lead to improved outcomes for stroke survivors.

What evidence suggests that this trial's treatments could be effective for improving balance in stroke patients?

Research has shown that robotic balance training combined with high-definition brain stimulation can greatly improve balance, walking, and movement in stroke patients. In this trial, participants in the RBT + Active HD-tDCS Group will receive this combined treatment. One study found that these treatments together help the brain better utilize areas involved in movement and balance, leading to improved results. Another study demonstrated that combining robotic training with brain stimulation enhances leg function and brain connectivity in stroke patients. The evidence suggests that this combined approach may effectively aid recovery for those facing balance and movement challenges after a stroke.16789

Who Is on the Research Team?

GF

Gail Forrest, PhD

Principal Investigator

Kessler Foundation

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Vikram Shenoy Handiru,, PhD

Principal Investigator

Kessler Foundation

GY

Guang Yue, PhD

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

The NEUROBALANCE Stroke trial is for individuals who have had a stroke at least 6 months ago and are still struggling with balance and walking. They should be able to participate in rehabilitation training sessions.

Inclusion Criteria

Not planning to change medication in the next four months
I can understand and follow study instructions.
I have trouble with balance and posture, scoring 50 or less on the BBS.
See 4 more

Exclusion Criteria

Contraindication for MRI scan (presence of metal implants, claustrophobia)
Contraindications to MRI, including the presence of non-titanium metallic implants, claustrophobia, etc.
Any other neurological injury or psychiatric conditions (e.g., severe anxiety or schizophrenia etc.)
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 15 training sessions over 5 weeks, involving robotic balance training and brain stimulation

5 weeks
15 visits (in-person)

Follow-up

Participants are monitored for balance recovery and retention post-training

8 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Combined (Robotic balance training and high-definition transcranial direct current stimulation)
  • Standard of Care Balance Training
Trial Overview This study tests if robotic balance training combined with brain stimulation can help improve balance in people who've had a stroke. Participants will either get real or fake brain stimulation, or just standard rehab, to see which method works best.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: SOC Control GroupExperimental Treatment1 Intervention
Group II: RBT + Active HD-tDCS GroupExperimental Treatment1 Intervention
Group III: RBT + Sham HD-tDCS GroupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials
190
Recruited
11,300+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials
83
Recruited
10,500+

Citations

Simultaneous high-definition transcranial direct current ...In this study, we found significant improvements in gait, balance, and motor functions after real HD-tDCS application in combination with RAGT.
Kiran Karunakaran, PhD, and Vikram Shenoy Handiru ...This intervention will result in improved and efficient recruitment of cognitive and sensorimotor brain regions during gait and balance and will ...
Effectiveness of Robot-Assisted Gait Training in Stroke ...This systematic review and meta-analysis evaluated the effectiveness of combining RAGT with conventional rehabilitation in improving gait-related outcomes ...
Robotic Balance Training + Brain Stimulation for StrokeTrial Overview This study tests if robotic balance training combined with brain stimulation can help improve balance in people who've had a stroke. ...
The effects of combining anodal transcranial direct current ...The combination of anodal tDCS and RAGT can enhance lower limb motor function in stroke patients, while also modulating the connectivity within ...
NEUROBALANCE Training to Improve Postural Control in ...Our proposed study, "NEUROBALANCE," aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive ...
Transcranial direct current stimulation combined with robotic ...Current findings suggest that tDCS combined with RT does not improve upper limb function, strength, spasticity, functional independence or velocity of movement ...
Effects of robotic gait training after stroke: A meta-analysisAccording to moderate-quality evidence, RTT can improve walking distance and functional ambulation after stroke [4]. Walking speed is higher during robot- ...
Transcranial Direct Current Stimulation for Improving ...The data indicate mixed results of tDCS for improving balance in older adults with and without stroke.
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